Notice Type
Departmental
Notice Title

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiance
Empagliflozin 10mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Jardiance
Empagliflozin 25mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Oxycodone Actavis
Oxycodone hydrochloride 5mg equivalent to Oxycodone 4.48mg
Capsule
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria
Actavis UK Limited, North Devon, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Oxycodone Actavis
Oxycodone hydrochloride 10mg equivalent to Oxycodone 8.96mg
Capsule
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria
Actavis UK Limited, North Devon, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Oxycodone Actavis
Oxycodone hydrochloride 20mg equivalent to Oxycodone 17.93mg
Capsule
Actavis New Zealand Limited
Actavis ehf, Hafnarfjordur, Iceland
Balkanpharma Dupnitsa AD, Dupnitsa, Bulgaria
Actavis UK Limited, North Devon, United Kingdom

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Paracetamol Children 3 Months - 6 Years
Paracetamol 2.4%w/w
Oral suspension
Multichem NZ Limited
Meditab Specialities Pvt Limited, Maharashtra, India

Dated this 16th day of April 2015.

SARAH READER, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).